- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03954964
Increasing Awareness of Opioid Disposal in the Orthopedic Patient Population
March 25, 2020 updated by: Christine D. Aliory, Mayo Clinic
Researchers are trying to determine if providing education on proper disposal of unused opioid medications to the orthopedic patient undergoing a planned hip or knee total joint replacement will increase the percentage of patients who properly dispose of unused opioids.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult 18 + years
- Planned total hip or knee replacement surgery
- English speaking
Exclusion Criteria:
- Pediatric patients 17 and younger
- Non-English speaking patients
- Total joint replacement surgery other than Hip and Knee
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
Subjects participating in a total joint class for patients undergoing planned hip and knee total joint replacement.
|
|
Experimental: Intervention Group
Subjects participating in a total joint class for patients undergoing planned hip and knee total joint replacement will receive additional education about the disposal of opioids.
|
Current class curriculum including education about pain management with additional education about the disposal of opioids.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disposal of unused prescription pain medication
Time Frame: 12 weeks post operative
|
Number of subjects to self-report disposal of unused prescription pain medication on the twelve week post operative visit survey
|
12 weeks post operative
|
Use of medication deactivation bag
Time Frame: 12 weeks post operative
|
Number of subjects to self-report disposal of unused prescription pain medication via the medication deactivation bag on the twelve week post operative visit survey
|
12 weeks post operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christine Aliory, APRN, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 3, 2019
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
May 16, 2019
First Submitted That Met QC Criteria
May 16, 2019
First Posted (Actual)
May 17, 2019
Study Record Updates
Last Update Posted (Actual)
March 26, 2020
Last Update Submitted That Met QC Criteria
March 25, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-011832
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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